Somryst— 510(k) K191716
Substantially EquivalentPear Therapeutics, Inc.
FDA 510(k) clearance K191716 for Somryst, Substantially Equivalent on 2020-03-23. Applicant: Pear Therapeutics, Inc.. Device class: 2.
Clearance details
- Applicant
- Pear Therapeutics, Inc.
- Product code
- Code QVO
- Device class
- Class 2
- Regulation
- 21 CFR 882.5801
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Francisco, CA, US
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